Together, Let’s Make A Difference.

At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.

Every team member, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry’s top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.

We believe our people are our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come.

Do you enjoy working in a dynamic, inspiring team with an amazing culture? If you do, then Ajinomoto Bio-Pharma Services is the place for you.

We are currently seeking an Analytical Associate III to support Ajinomoto Bio-Pharma Services’ manufacturing. The Analytical Associate III develops, qualifies, validates, and transfers analytical methods to support drug product and drug substance manufacturing and fill-finish including release and stability testing. The Associate III captures testing and development data in an electronic lab notebook and test forms while maintaining compliance and data integrity standards. The Analytical Associate III will expand their knowledge and experience in ICH, GDP, GMP and regulatory guidelines on method development, qualification, validation and technical writing.

Responsibilities:

• Follows method standard operating procedures (SOPs) and conducts analytical method transfer. Develops, qualifies, and validates analytical methods with minimal supervision.
• Investigates, creates, and develops new methods and technologies for project advancement under limited supervision.
• Supports assay improvement and process improvement implementation.
• Analyzes in-process, release and stability samples by battery of analytical methods and troubleshoots when necessary.
• Writes SOPs, qualification and validation protocols, and reports in collaboration with other team members.
• Communicates with internal & external stakeholders on project status, timelines, deliverables; May act as project lead or department representative for project.
• Responsible for data review, interpretation and presenting data at team and group meetings.
• May work with Band 4 and Band 5 highly potent compounds.
• Coordinates with vendors for equipment service and training needs.
• Recommends new tools, equipment and software for CapEx purchases.
• Utilizes complex software packages such as LIMS, Agilent UV software, and other instrument software packages.
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies Ajinomoto Bio-Pharma Services’ cultural values and aligns daily actions with department goals and company culture.

Requirements:

• Bachelor’s degree in a Life Sciences discipline or equivalent required.
• Minimum of 4 years of relevant experience in a laboratory setting with an emphasis on HPLC, Uv-Vis, ELISA, SDS-PAGE and/or wet lab methods.
• Experience with analytical method transfer, qualification, and validation; hands-on experience in HPLC and other chromatographic, spectrophotometric and wet lab chemistry methods is required; Demonstrated ability to serve as an SME in at least one of the previously mentioned methods.
• Experience with one or more of the following is preferred: LC-MS, FTIR, dynamic light scattering.
• Familiarity with Agilent ELN, Chromeleon HPLC, Softmax Pro, and SoloVPE applications a plus.
• Critical thinking and excellent verbal and written communication skills.
• Ability to collaborate well internally in a matrix environment.
• Must be familiar with Microsoft Office applications.

We provide a Total Rewards package designed to make life better – both at work and at home.

• Annual Bonus Opportunities for All Employees
• 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
• Paid Parental Leave
• Annual Company Shutdown in December
• Comprehensive Medical, Dental + Vision
• 401K Company Match + Immediate Vesting
• Backup Daycare and Eldercare
• Monthly Employee Appreciation Events and Food Truck Fridays
• Employee Discount Programs
• Tuition Reimbursement
• Casual Dress Code
• Wellness Programs
• Community Outreach Opportunities

If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the “Careers” section. Please be sure to note where you saw our ad posting.

New hires will pass a background check and drug screen as a condition of employment.

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.